TDMS Study 05169-01 Pathology Tables
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: HLA, VA DATE: 09/18/94
EXP: 05169 C. I. DIRECT BLUE 15 TIME: 03:51:08
TEST: 01 CAGES FROM 0000 TO LAST CAGE PAGE: 1
TEST TYPE: CHRONIC ROUTE: DOSED WATER NTP C#: 61290
CONT: NO1ES9565503 CAS: 2429-74-5
PATHOLOGIST: B. ULLAND S. EUSTIS
--------------------------------------------------------------------------------
REASONS FOR REMOVAL:
ALL
REMOVAL DATE RANGE:
ALL
TREATMENT GROUPS:
INCLUDE ALL
NTP STATISTICAL ANALYSIS OF SURVIVAL DATA REPORT: PEIRPT11
LAB: HLA, VA DATE: 09/18/94
EXP: 05169 C. I. DIRECT BLUE 15 TIME: 03:51:08
TEST: 01 CAGES FROM 0000 TO LAST CAGE
TEST TYPE: CHRONIC ROUTE: DOSED WATER NTP C#: 61290
CONT: NO1ES9565503 CAS: 2429-74-5
PATHOLOGIST: B. ULLAND S. EUSTIS
C. I. DIRECT BLUE 15
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 680 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = CONTROL |
| --------------------- |
| |
| TOTAL 70 UNCENSORED DEATHS 13 CENSORED DEATHS 20 TERMINAL 37 |
| |
| UNCENSORED DEATHS |
| 333 357 445 495 501 558 565 589 637 642 |
| 659 659 663 |
| CENSORED DEATHS |
| 276 276 276 276 276 276 276 276 276 276 |
| 458 458 458 458 458 458 458 458 458 458 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.063 |
| --------------------- |
| |
| TOTAL 45 UNCENSORED DEATHS 27 CENSORED DEATHS 10 TERMINAL 8 |
| |
| UNCENSORED DEATHS |
| 293 316 421 435 512 513 544 566 578 578 |
| 579 583 591 592 614 619 620 624 626 632 |
| 646 646 646 646 646 660 668 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.125 |
| --------------------- |
| |
| TOTAL 75 UNCENSORED DEATHS 54 CENSORED DEATHS 10 TERMINAL 11 |
| |
| UNCENSORED DEATHS |
| 323 372 402 451 460 472 502 505 505 506 |
| 530 534 559 570 572 574 575 577 579 583 |
| 585 595 605 606 611 617 619 623 626 626 |
| 628 629 630 632 632 632 633 633 637 638 |
| 640 640 641 646 646 646 646 646 646 670 |
| 670 672 673 679 |
| CENSORED DEATHS |
| 458 458 458 458 458 458 458 458 458 458 |
| |
==================================================================================
C. I. DIRECT BLUE 15
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 680 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0.25 |
| --------------------- |
| |
| TOTAL 70 UNCENSORED DEATHS 46 CENSORED DEATHS 22 TERMINAL 2 |
| |
| UNCENSORED DEATHS |
| 243 317 372 372 372 408 449 452 460 460 |
| 463 465 479 495 495 502 505 506 506 520 |
| 521 535 539 543 547 551 556 561 565 565 |
| 568 570 579 583 592 600 612 613 621 624 |
| 645 646 646 646 656 659 |
| CENSORED DEATHS |
| 85 85 276 276 276 276 276 276 276 276 |
| 276 276 458 458 458 458 458 458 458 458 |
| 458 458 |
| |
==================================================================================
C. I. DIRECT BLUE 15
STATISTICAL ANALYSIS OF SURVIVAL DATA
MALE RATS
FIRST TERMINAL SACRIFICE AT 680 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 680 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|CONTROL | 100.0 100.0 100.0 96.7 96.7 95.0 91.0 84.9 74.8 74.8 |
| | |
| | |
|0.063 | 100.0 100.0 100.0 95.6 93.3 91.1 82.3 61.7 26.5 23.5 |
| | |
| | |
|0.125 | 100.0 100.0 100.0 98.7 96.0 91.6 82.3 65.2 24.8 17.1 |
| | |
| | |
|0.25 | 100.0 100.0 98.5 96.8 89.9 75.6 51.9 25.9 4.3 4.3 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| CONTROL 0.063 0.125 0.25 |
| |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 74.8% 23.5% 17.1% 4.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P<0.001 P<0.001 P<0.001 P<0.001 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 546.4 570.1 587.9 525.7 |
|NATURAL DEATHS (C) | (31.5) (19.0) (10.7) (13.8) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 565.8 564.8 584.1 472.2 |
|(STANDARD ERROR) | (18.2) (15.5) (10.3) (16.4) |
| | |
==================================================================================
(A) FIRST TERMINAL SACRIFICE
(B) THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
(COX,1972). NEGATIVE TRENDS ARE INDICATED BY "N".
(C) MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
(D) MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
C. I. DIRECT BLUE 15
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 682 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = CONTROL |
| --------------------- |
| |
| TOTAL 70 UNCENSORED DEATHS 10 CENSORED DEATHS 20 TERMINAL 40 |
| |
| UNCENSORED DEATHS |
| 292 500 502 550 624 659 664 666 669 676 |
| CENSORED DEATHS |
| 276 276 276 276 276 276 276 276 276 276 |
| 459 459 459 459 459 459 459 459 459 459 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.063 |
| --------------------- |
| |
| TOTAL 45 UNCENSORED DEATHS 22 CENSORED DEATHS 10 TERMINAL 13 |
| |
| UNCENSORED DEATHS |
| 463 465 495 506 506 506 529 535 540 558 |
| 565 568 576 579 622 635 635 646 647 647 |
| 647 653 |
| CENSORED DEATHS |
| 459 459 459 459 459 459 459 459 459 459 |
| |
|--------------------------------------------------------------------------------|
| DOSE = 0.125 |
| --------------------- |
| |
| TOTAL 75 UNCENSORED DEATHS 43 CENSORED DEATHS 10 TERMINAL 22 |
| |
| UNCENSORED DEATHS |
| 253 368 372 372 408 432 432 449 460 479 |
| 495 524 527 529 555 559 583 589 592 598 |
| 616 620 625 625 626 630 630 633 633 638 |
| 640 640 645 646 646 654 659 659 659 666 |
| 673 680 680 |
| CENSORED DEATHS |
| 459 459 459 459 459 459 459 459 459 459 |
| |
==================================================================================
C. I. DIRECT BLUE 15
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 682 DAYS
INDIVIDUAL SURVIVAL TIMES (DAYS)
==================================================================================
| DOSE = 0.25 |
| --------------------- |
| |
| TOTAL 70 UNCENSORED DEATHS 46 CENSORED DEATHS 20 TERMINAL 4 |
| |
| UNCENSORED DEATHS |
| 296 316 339 359 372 402 408 408 453 463 |
| 466 474 484 486 495 495 502 502 513 513 |
| 527 534 547 564 578 581 585 585 585 592 |
| 592 600 600 607 613 619 620 623 624 624 |
| 635 645 646 646 646 646 |
| CENSORED DEATHS |
| 276 276 276 276 276 276 276 276 276 276 |
| 459 459 459 459 459 459 459 459 459 459 |
| |
==================================================================================
C. I. DIRECT BLUE 15
STATISTICAL ANALYSIS OF SURVIVAL DATA
FEMALE RATS
FIRST TERMINAL SACRIFICE AT 682 DAYS
==================================================================================
| KAPLAN-MEIER SURVIVAL PROBABILITY ESTIMATES (%) |
| |
|--------------------------------------------------------------------------------|
| DOSE TIME (DAYS) |
| 90 180 270 365 425 485 545 605 665 682 (A) |
| |
|--------------------------------------------------------------------------------|
| | |
|CONTROL | 100.0 100.0 100.0 98.3 98.3 98.3 94.3 92.3 86.3 80.3 |
| | |
| | |
|0.063 | 100.0 100.0 100.0 100.0 100.0 94.3 74.3 60.0 37.1 37.1 |
| | |
| | |
|0.125 | 100.0 100.0 98.7 98.7 93.3 86.2 79.9 70.5 40.7 34.5 |
| | |
| | |
|0.25 | 100.0 100.0 100.0 93.3 86.7 76.7 58.0 35.2 8.3 8.3 |
| | |
| | |
==================================================================================
==================================================================================
| SURVIVAL SUMMARY STATISTICS |
| |
| |
|--------------------------------------------------------------------------------|
| DOSE |
| |
| CONTROL 0.063 0.125 0.25 |
| |
|--------------------------------------------------------------------------------|
|SURVIVAL AT END OF STUDY| 80.3% 37.1% 34.5% 8.3% |
|(KAPLAN-MEIER) | |
| | |
|SIGNIFICANCE (B) | P<0.001 P<0.001 P<0.001 P<0.001 |
|(LIFE TABLE) | |
| | |
|MEAN DAY OF | 580.2 569.2 567.4 530.7 |
|NATURAL DEATHS (C) | (38.9) (13.6) (16.1) (14.4) |
|(STANDARD ERROR) | |
| | |
|MEAN LIFE SPAN (D) | 577.6 577.3 586.6 492.7 |
|(STANDARD ERROR) | (18.3) (13.7) (12.3) (15.2) |
| | |
==================================================================================
(A) FIRST TERMINAL SACRIFICE
(B) THE FIRST ENTRY IS THE TREND TEST (TARONE, 1975) RESULT.
SUBSEQUENT ENTRIES ARE THE RESULTS OF PAIRWISE TESTS
(COX,1972). NEGATIVE TRENDS ARE INDICATED BY "N".
(C) MEAN OF ALL UNCENSORED DEATHS PRIOR TO TERMINAL SACRIFICE
(D) MEAN OF ALL DEATHS (UNCENSORED, CENSORED, TERMINAL SACRIFICE)
C. I. DIRECT BLUE 15
KAPLAN-MEIER SURVIVAL CURVES
CONTROL = 1
0.063 = 2
0.125 = 3
0.25 = 4
------------------------------------------------------ SPECIES=RATS SEX=MALE -------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
100 + 1 4 2 3 1
| 4 2 23 1 1 3 3 1
| 2 3 2 133 1
| 4 4 2 2 3 3 11
90 + 4 2 4 1 32 11
| 44 1 1
| 32 33 2 1 1
| 44 3 2 32 11
80 + 323 2 1 1
| 4 4
| 4 4 3 3 1 1
| 44 33
P 70 + 4 4 22
E | 22 3
R |
C | 4 4 2 3 23
E 60 + 22
N | 4 4 33
T | 4 4
| 44 22
S 50 + 33
U | 44 22
R | 44 2 2
V |
I 40 + 44 33
V |
A | 4 4 3 3
L | 44
30 + 44 2 2
| 44 22
| 4 4 3 3
| 44 2 2
20 + 44 33
| 4 4 3 3
|
|
10 +
| 444
| 4 4
|
0 +
|
---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
0 10 20 30 40 50 60 70 80 90 100
WEEK
NOTE: 20 obs hidden.
C. I. DIRECT BLUE 15
KAPLAN-MEIER SURVIVAL CURVES
CONTROL = 1
0.063 = 2
0.125 = 3
0.25 = 4
----------------------------------------------------- SPECIES=RATS SEX=FEMALE ------------------------------------------------------
Plot of SURVIVAL*WEEK. Symbol is value of DOSE.
|
100 + 1 3 1 4 2
| 3 1 4 4 4 33 1
| 4 4 3 3 2 21 1
| 4 4 43 3 2 2 1 1
90 + 44 3 33 1 1
| 4 43 3 11
| 4 4 3 3 3
| 2 32 11
80 + 4 4 4 22 3 1 1
| 2 2 3 3
| 44 2 2 33
| 22 33
P 70 + 44 3 33
E | 4 4 22 33
R | 2 2
C | 4 4
E 60 + 44 2 233
N | 4 4 2 23
T | 4 4 4
| 23 2
S 50 + 44
U | 33
R | 33
V | 44
I 40 + 44 22333
V | 2 3 2
A | 44 3
L | 4 4
30 + 44
|
| 44
|
20 + 44
| 4 4
|
|
10 +
| 4 4
|
|
0 +
|
---+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+-----------+--
0 10 20 30 40 50 60 70 80 90 100
WEEK
NOTE: 17 obs hidden.
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